Methods of making medical solutions and related systems

ABSTRACT

This disclosure relates to making medical solutions. In certain aspects, a method is performed by a data processing apparatus. The method includes introducing liquid into a container that contains a dissolvable solid concentrate in a manner so that a layer of solution above the solid concentrate is maintained at a depth that allows the liquid introduced into the container to agitate the solution adjacent to the solid concentrate to cause mixing of the solid concentrate with the solution.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional of and claims priority under 35 U.S.C.§120 to U.S. Ser. No. 13/630,123, filed Sep. 28, 2012. The contents ofthis priority application are hereby incorporated by reference in itsentirety.

TECHNICAL FIELD

This invention relates to methods of making medical solutions andrelated systems.

BACKGROUND

Renal dysfunction or failure and, in particular, end-stage renaldisease, causes the body to lose the ability to remove water andminerals and excrete harmful metabolites, maintain acid-base balance andcontrol electrolyte and mineral concentrations within physiologicalranges. Toxic uremic waste metabolites, including urea, creatinine, anduric acid, accumulate in the body's tissues which can result in aperson's death if the filtration function of the kidney is not replaced.

Dialysis is commonly used to replace kidney function by removing thesewaste toxins and excess water. In one type of dialysistreatment—hemodialysis—toxins are filtered from a patient's bloodexternally in a hemodialysis machine. Blood passes from the patientthrough a dialyzer separated by a semi-permeable membrane from a largevolume of externally-supplied dialysis solution. The waste and toxinsdialyze out of the blood through the semi-permeable membrane into thedialysis solution, which is then discarded.

The dialysis solutions or dialysates used during hemodialysis typicallycontain sodium chloride and other electrolytes, such as calciumchloride, or potassium chloride, a buffer substance, such asbicarbonate, or acetate and acid to establish a physiological pH, plusoptionally, glucose or another osmotic agent.

SUMMARY

In one aspect of the invention a method is performed by a dataprocessing apparatus. The method includes introducing liquid into acontainer that contains a dissolvable solid concentrate in a manner sothat a layer of solution above the solid concentrate is maintained at adepth that allows the liquid introduced into the container to agitatethe solution adjacent to the solid concentrate to cause mixing of thesolid concentrate with the solution.

In another aspect of the invention a dialysis system includes acontainer containing a dissolvable solid concentrate, an input lineconnected to the container and to a valve that controls the flow ofliquid into the container, an output line connected to the container andto a pump, and a data processing apparatus connected to the valve andconfigured for introducing liquid into the container through the line ina manner so that a layer of solution above the solid concentrate ismaintained at a depth that allows the liquid introduced into thecontainer to agitate the solution adjacent to the solid concentrate tocause mixing of the solid concentrate with the solution.

Implementations can include one or more of the following features.

In certain implementations, the solid concentrate is a salt.

In certain implementations, the salt is sodium bicarbonate.

In certain implementations, the method includes obtaining a measurementof a volume of solution pumped from the container by a pump during afirst period of time, and determining a second period of time based onthe measurement.

In certain implementations, introducing the liquid comprises opening avalve that controls the flow of the liquid into the container for thesecond period of time.

In certain implementations, the first period of time is based on anumber of cycles of a balance chamber connected to the pump.

In certain implementations, the method includes pumping the solution toa dialyzer.

In certain implementations, the depth of the layer of solution is 0.5 to1.5 inch.

In certain implementations, the method includes obtaining a measurementof pressure within the container, comparing the measurement to anexpected pressure, and determining a period of time based on thecomparison;

In certain implementations, introducing the liquid includes opening avalve that controls the flow of the liquid into the container for theperiod of time.

In certain implementations, the method includes obtaining a measurementof the weight of the container, comparing the measurement to an expectedweight, and determining a period of time based on the comparison.

Implementations can include one or more of the following advantages.

In some implementations, the methods described provide improvedutilization of a solid concentrate (e.g., a powdered sodium bicarbonateconcentrate) in a dialysis system. Using conventional methods, excessliquid is often times added to a medical solution container (e.g., asodium bicarbonate solution container) during dialysis to reduce thelikelihood of pumping air from the container as the container is emptiedduring treatment. As a result, a thick layer of solution (e.g., sodiumbicarbonate solution) tends to form over the solid concentrate at thebottom of the container. The thick layer of solution dissipates theforce of additional liquid being added to the container, and therebylimits agitation of the solution near its interface with the solidconcentrate. This can decrease dissolution of the solid concentrate intothe solution and can thus prevent the solution from becoming saturated.The inventors have found that by limiting the layer of liquid orsolution covering the layer of solid concentrate to 0.5 to 1.5 inch, theforce of new liquid being added to (e.g., dropped into) the container issufficient to agitate the solid concentrate and thus promote dissolutionof the solid concentrate within the added liquid. At the same time, thelayer of liquid or solution is sufficiently thick to prevent air frombeing pumped from the container as the container is emptied duringtreatment. In this manner, more of the solid concentrate is dissolvedinto the liquid, less of the solid concentrate is wasted, and theduration of the dialysis treatment without intervention is increased.

In addition to the benefits discussed above, maintaining a thinner layerof liquid or solution over the layer of solid concentrate at the bottomof the container can reduce the amount of time required to empty thecontainer after completion of a treatment. As a result, the total amountof time required by the clinician to complete post-treatment procedurescan be reduced such that more of the clinician's time can be spentcaring for patients.

DESCRIPTION OF FIGURES

FIG. 1 is a schematic diagram of a hemodialysis system that is connectedto a patient.

FIG. 2 is a schematic diagram of a dialysate circuit and associatedcomponents of the hemodialysis system of FIG. 1.

FIG. 3 is a representative partially cross-sectioned view of acollapsible bag of the hemodialysis system of FIG. 1 that contains apowdered sodium bicarbonate concentrate.

FIG. 4 is a graph depicting the conductivity of a sodium bicarbonatesolution flowing from the collapsible bag of the hemodialysis system ofFIG. 1 during a dialysis treatment.

FIG. 5 is a flow chart depicting a method of early detection of a lowsodium bicarbonate level in a solution flowing from the collapsible bagof the hemodialysis system of FIG. 1.

DETAILED DESCRIPTION

In general, the invention relates to methods of making medical solutionsand related systems. In some aspects of the invention, a dialysis system(e.g., a hemodialysis system) includes a controller that controls thedialysis system to carry out a dialysis treatment. The controllerreceives signals from a pump that pumps a medical solution (e.g., asodium bicarbonate solution) from a container, such as a bag, into afeeder line. By monitoring the volume of solution pumped from thecontainer, the controller can determine a volume of liquid to add to thecontainer to maintain a liquid level in the container that facilitatesthe dissolution of a solid concentrate (e.g., a powdered sodiumbicarbonate concentrate) into the liquid or solution. The solution abovethe solid concentrate can, for example, have a depth that is maintainedwithin a desired range to ensure that the introduction of additionalliquid into the container will agitate the portion of the solutionadjacent the solid concentrate and cause the solid concentrate to mixwith the solution.

Referring to FIG. 1, a dialysis system 10 includes a dialysis machine 12that includes a subsystem 15 for preparing a sodium bicarbonate solutionfrom a powdered sodium bicarbonate concentrate to form dialysate. Duringtreatment a disposable fluid line set and a dialyzer 11 is connected tothe machine 12 and to a patient 13 to permit the patient's blood tocirculate through the fluid line set and dialyzer 11. Fluid lines alsoextend from the machine 12 to the dialyzer 11 to allow the dialysate topass through the dialyzer 11 with the blood. As the blood and dialysatepass through the dialyzer 11, toxins move across a semi-permeablesurface of the dialyzer 11 from the blood to the dialysate.

FIG. 2 illustrates a representative hydraulic arrangement of thedialysis system 10. Many of the illustrated components are housed insidethe machine 12 and are thus not visible in FIG. 1. By way of a generaloverview of the operation, the system 10 includes main fluid linesegments 20 a-d (collectively referred to as a mainline 20) that arefluidly coupled to a fluid source 22 at one end, and to the dialyzer 11at the other end, with various optional assemblies disposed along themainline 20. In some implementations, optional assemblies are disposedalong the mainline 20 for preparing the sodium bicarbonate solution ordialysate and may include a hydroblock 24 and one or more balancingchambers 26, 28.

Line segments 30 a-f (collectively referred to as a return line 30) fromthe dialyzer 11 provides return flow from the dialyzer 11 to a drain 34.Subassemblies such as an air separation chamber 36 and a heat exchanger38 are provided along the return line 30. It is noted that not allelements of the illustrated hydraulic arrangement are necessary to thestructure and operation of the subsystem 15 for preparing a sodiumbicarbonate solution from a powdered sodium bicarbonate concentrate,although a general explanation is provided herein in the interest ofcompleteness.

Turning now to the specifics of the illustrated hydraulic arrangement,the fluid source 22 includes any appropriate type of liquid or liquids,such as a reverse osmosis water (RO water) source. Liquid from the fluidsource 22 flows through the mainline segment 20 a to the hydroblock 24.In some implementations, the heat exchanger 38, a pressure regulator 40,and a control valve 42 are provided along the mainline segment 20 abetween the fluid source 22 and the hydroblock 24. The heat exchanger 38heats the liquid somewhat with heat from the return spent dialysate, aswill be discussed below.

The hydroblock 24 is a multichambered unit (chambers 24 a-24 e beingillustrated). The liquid is heated by a heater 41 in chamber 24 b andvented to a vent 43 in chamber 24 c as the liquid flows through thevarious chambers 24 a-e of the hydroblock 24. The liquid temperaturewithin the hydroblock 24 is monitored and/or controlled by a controlthermostat 44. A deaeration pump 46 pumps liquid between the fourth andfifth chambers 24 d, 24 e of the hydroblock 24 to return the liquid tothe mainline segment 20 b.

Leaving the hydroblock 24, the mainline segment 20 b bifurcates at abranch point 50. Valves 52, 54 control the flow of liquid to thecontinuing mainline segment 20 c and a subsystem line 56, respectively.If the valve 54 is closed and the valve 52 is open, the liquid continuesthrough the valve 52 to the mainline segment 20 c. Conversely, if thevalve 54 is open and the valve 52 is closed, liquid proceeds through thevalve 54 to the subsystem line 56. As with all of the valves in thisdisclosure, the valves 52, 54 may be simple shut-off valves, or othermultiposition valves. In alternative embodiments, the valves 52, 54 arereplaced by a single valve that includes positions that arrest flowentirely, that direct flow to the subsystem line 56, or that direct flowalong the mainline segment 20 c.

The subsystem line 56 connects flow from the mainline segment 20 b tothe subsystem 15 for preparing a sodium bicarbonate solution, as will beexplained in greater detail below. After leaving the subsystem 15, thesodium bicarbonate solution is returned to the mainline segment 20 c atjunction 58. The continuing mainline segment 20 c directs flow to thebalance chambers 26, 28. Flow through the balancing chambers 26, 28 iscontrolled by valves 62-69. Each of the balancing chambers 26, 28includes two separate subchambers separated by a flexible membrane, thesignificance of which will be discussed below. Flow from the subsystem15 flows into the respective balancing chambers 26, 28 through valves 62and 64, and out from the balancing chambers 26, 28 through valves 66,68. Valves 63, 65, 67, and 69 control flow of spent dialysate, asfurther described below.

Leaving the balancing chambers 26, 28, the solution is directed throughmainline segment 20 d. Flow to and from the dialyzer 11 is controlled bya pair of control valves 70, 72 disposed along the mainline segment 20 dand the return line segment 30 a, respectively, as well as a bypassvalve 74 disposed in bypass line 30 b between the mainline segment 20 dand the return line segment 30 a. Thus, dialysate from the balancingchambers 26, 28 flowing through mainline segment 20 d moves on to thedialyzer 11 when dialyzer inlet valve 70 is in the open configurationand bypass valve 74 in the bypass line 30 b is in the closed position.

As the dialysate flows through the dialyzer 11 so does a patient'sblood. As a result, toxins, such as urea, are transferred across asemi-permeable structure (e.g., semi-permeable microtubes) of thedialyzer 11 from the patient's blood to the dialysate.

Following the dialyzer 11, spent dialysate passes the control valve 72to return to the machine 12 through return line segments 30 a and 30 cwith the bypass valve 74 in the closed position. To ensure accurateoperation of the balancing chambers 26, 28, as discussed below, spentdialysate passes into the air separation chamber 36 before reaching thebalance chambers 26 and 28. From the air separation chamber 36,separated gases, and potentially fluid, are passed through return linesegment 30 d to the drain 34 by opening shutoff valves 76 and 80. Returndialysate, from which the gases have been separated in the airseparation chamber 36, may be pumped by flow pump 78 through return linesegment 30 e to one or both of the balance chambers 26, 28 throughvalves 63, 65. Leaving the balance chambers 26, 28 through valves 67,69, respectively, the spent dialysate is directed to a heat exchanger 38and the drain 34 by way of return line segment 30 f Overall flow to thedrain 34 is controlled by shutoff valve 80.

Within the balance chambers 26, 28, fresh dialysate from the subsystem15 passes along one side of the internal membranes, while spentdialysate passes along the other side of the internal membranes. Pumpingof spent dialysate from line segment 30 e along one side of the membranewith fresh dialysate passing along the other side of the membrane frommainline segment 20 c results in a balanced provision of dialysate fromand to the dialyzer 11 during use.

The structure and operation of the subsystem 15 for preparation of thesodium bicarbonate solution will now be explained. Still referring toFIG. 2, liquid flowing through the mainline segment 20 b from thehydroblock 24 is directed to the subsystem 15 by opening the controlvalve 54 and closing the control valve 52 at adjacent junction 50 toprovide flow to the subsystem line 56. To prepare the sodium bicarbonatesolution, liquid from the subsystem line 56 enters a bag 82, whichcontains a powdered sodium bicarbonate concentrate. During the fillingprocess, the valve 54 periodically closes allowing a pressure sensor 117to read the pressure within the bag 82. The bag can be filled until athreshold pressure is reached. The threshold pressure is typically about150 mmHg. During treatment the pressure is about 90 mmHg at the start ofthe treatment and about 20 mmHg at the end of the treatment. In someimplementations, the threshold pressure is 90 mmHg. The liquid fills thebag and saturates the dry form sodium bicarbonate concentrate that sitsat the bottom of the bag 82. The bag 82 can, for example, be acollapsible, replaceable bag that encloses the powdered sodiumbicarbonate concentrate.

An example of a suitable bag 82 is shown in FIG. 3. In this partiallycross-sectioned view, the bag 82 includes a protective cover 94. In someimplementations, the bag 82 is coupled to the subsystem 15 by aconnector 88 having an inlet 90 and an outlet 92. Although the inlet 90and outlet 92 are shown in an upper portion of the bag 82, the inlet 90and outlet 92 may be disposed elsewhere, so long as the requisite mixingis obtained. For example, the inlet may be disposed in a lower portionof the bag 82 to allow the liquid to be injected upward into the bag 82to encourage agitation to facilitate mixing.

In order to allow the mixed sodium bicarbonate solution to be withdrawnfrom the bag 82 when it is not completely full, the outlet 92 originatesbelow the level of liquid in the bag 82. In some implementations, a tube96 having a lower opening 98 is fluidly coupled to the outlet 92 suchthat the opening 98 is disposed in a lower portion of the bag 82, thatis, below the liquid level. The tube 96 sits atop a layer of powderedsodium bicarbonate concentrate 93 at the bottom of the bag 82. Toinhibit the intake of powdered sodium bicarbonate that is not yetdissolved, a filter 100 is disposed at the opening 98. The filter 100can be made of any appropriate material, such as porous polyethylene.The bag 82 and connector 88 are typically made of high densitypolyethylene, but other suitable materials can be used.

Carbon dioxide will typically be generated from the initial contactbetween the liquid and the sodium bicarbonate powder. Residual air isalso often disposed within the bag 82. As explained above, in order toprovide proper removal of the sodium bicarbonate solution from the bag82, the opening 98 into the outlet 92 of the bag 82 is maintained belowthe surface of the liquid contained therein. It will thus be appreciatedthat a reduction of gases disposed within the bag 82 typically providesmore space for the introduction of liquid.

In general, during operation the bag 82 includes a layer of sodiumbicarbonate solution 95 over the layer of powdered sodium bicarbonateconcentrate 93 because the powdered sodium bicarbonate is denser thanthe solution and rests on the bottom of the bag 82. As liquid 97 isadded to the bag 82 through inlet 90, the liquid 97 falls into the layerof solution 95 causing agitation in the portion of the solution directlyadjacent the layer of undissolved sodium bicarbonate powder and therebycausing the sodium bicarbonate powder to become mixed with the solution.This mixing action assists in the dissolution of the sodium bicarbonatepowder into the solution, and thus helps to ensure that the solutionbecomes saturated.

If the layer of solution 95 is too shallow (e.g., less than 0.5 inchabove the layer of sodium bicarbonate 93), then there may beinsufficient liquid to dissolve the dry form sodium bicarbonate. If thelayer of solution 95 is too deep (e.g., greater than 1.5 inch above thelayer of sodium bicarbonate 93), then the layer of liquid 95 will dampenthe added liquid 97 and there may not be sufficient agitation betweenthe liquid and the dry form sodium bicarbonate to adequately mix thesodium bicarbonate with the solution. As discussed below, in someimplementations, the system 10 is configured to maintain the layer ofsolution 95 at a thickness (or depth) of 0.5 inch to 1.5 inch above thelayer of sodium bicarbonate powder 93 to help ensure that adequatemixing of the sodium bicarbonate powder 93 with the solution 95 occursas supplemental liquid 97 is introduced into the bag 92.

Returning to FIG. 2, in order to expel air from the subsystem 15, an airseparation chamber 102 is provided downstream of the bag 82. The airseparation chamber 102, which is fluidly connected to the bag 82 by asubsystem line 103, is designed to remove both air residually disposedwithin the bag 82 and gases precipitating out of the bicarbonatesolution during operation of the subsystem 15. During operation, airrises to the top of the air separation chamber 102, while thebicarbonate solution settles to the bottom of the air separation chamber102. In use, bicarbonate solution is passed from the air separationchamber 102 to subsystem line 104, while gases are passed from the airseparation chamber 102 by operation of valve 106.

Turning first to the passage of bicarbonate solution from the airseparation chamber 102, flow through the subsystem line 104 iscontrolled by operation of a valve 107. When valve 107 is in the openposition and valve 106 is in the closed position, bicarbonate solutionflows through subsystem line 104 to a conductivity detector 110 thatincludes a conductivity cell 111 and a temperature detector 112. In someimplementations, the temperature detector 112 is a thermister, which isa resistor in which the resistance varies significantly withtemperature. The conductivity cell 111 measures the conductivity of orprovides a representative reading of the bicarbonate level of solutionleaving the air separation chamber 102. From the conductivity cell 111and temperature detector 112, a bicarbonate pump 113 pumps thebicarbonate solution to rejoin the mainline segment 20 c at junction 58,via which the bicarbonate solution is passed to one or both of thebalancing chambers 26, 28, and on to the dialyzer 11.

During normal operation, the air separation chamber 102 separates gasfrom the bicarbonate solution or dialysate progressing to the junction58 for delivery to the dialyzer 11, while the air separation chamber 36separates gas from spent dialysate returning from the dialyzer 11. Itwill be appreciated that this elimination of the gases in the dialysateflowing to and from the dialyzer 11 facilitates efficient and accurateoperation of the balancing chambers 26, 28 during regular operation ofthe system 10.

In order to determine if and when gas has accumulated in the airseparation chamber 102, an air sensor 124 is provided in the airseparation chamber 102. In some implementations, the air sensor 124 is atwo-pronged air detection probe located at the top of the air separationchamber 102 such that an electric current between the two prongs isdetected when liquid fills the chamber 102 to at least the level of theprongs. Conversely, when there is air in the chamber 102, the airbetween the two prongs acts as an insulator and electric current doesnot flow. A similar air sensor 126 is provided in air separation chamber36 to provide an indication of when valve 76 should be opened to allowpassage of gases from air separation chamber 36 to return line segment30 d.

Flow through the air separation chamber 102 is controlled by the controlvalve 106. If air is not detected in the air separation chamber 102, thecontrol valve 106 is closed, and the solution proceeds through subsystemline 104, advanced by the pump 113 to rejoin the mainline segment 20 cat junction 58. The solution is then passed on to the balance chambers26, 28 and to the mainline segment 20 d for delivery to the dialyzer 11,as explained above.

Conversely, if the air sensor 124 detects air in the air separationchamber 102, the control valve 106 is opened to vent gases from the airseparation chamber 102 to degassing line 122. The degassing line 122provides a fluid connection to the hydrochamber 24 such that gasesaccumulated in the air separation chamber 102 are passed to thehydrochamber 24. The degassing line 122 is connected to the thirdchamber 24 c of the hydrochamber 24. In use, only gases typically arereleased from the separation chamber 102 through the valve 106 for veryshort periods of time, rather than an air/sodium bicarbonate solutioncombination.

Some implementations further include a bypass line 128 in which a valve130 is disposed, coupling the degassing line 122 to the fourth chamber24 d. During cleaning modes of the machine, the valve 130 is opened inorder to relieve pressure built up within the hydrochamber 24.

To assist in the separation of gases from the fluid contained within thehydrochamber 24, the third chamber 24 c of the hydrochamber 24 includesa venting structure 43. Gases entering the third chamber 24 c from thedegassing line 122 rise upward through the fluid contained within thehydrochamber 24 to the upper portion of the third chamber 24 c to bevented through the venting structure 43 to a drain or the atmosphere132.

Under normal operation, only gases are typically vented from the airseparation chamber 102 through the degassing line 122 to thehydrochamber 24. In order to ensure that the valve 106 and air sensor124 are operating properly, that is, in order to monitor whether any ofthe sodium bicarbonate solution is being vented from the air separationchamber 102 to the hydrochamber 24 through the degassing line 122, aconductivity sensor 134 is provided between the hydrochamber 24 and thebag 82. In this way, a direct conductivity number is determined for thefluid as it flows from the hydrochamber 24 to the mainline segment 20 cor subsystem line 56.

The measured conductivity number is compared to a reference conductivitynumber for fluid that is not diluted with a sodium bicarbonate solution.If the measured conductivity number differs from the referenceconductivity by greater than a given amount or percentage, or if themeasured conductivity number does not fall within a predeterminedreference range, then further corrective action is taken. Furthercorrective action may include, by way of example, shutting down thesystem 10 or providing a warning light or the like that the subsystem15, the air separation chamber 102, the valve 106, and/or the sensor 124must be checked.

The conductivity sensor 134 is also utilized to supply a measuredconductivity number to a controller with regard to the liquidconductivity, as opposed to an estimated conductivity number, which isoften utilized in calculations related to operation of dialysis systems.For example, such systems often assume that the liquid, e.g., water, hasno conductivity. The measured conductivity number provided by theconductivity sensor 134 for liquid leaving the hydrochamber 24 isutilized in system calculations as opposed to an assumed or estimatedconductivity number. As a result, a more accurate conductivity numbercan be used.

The system 10 may include one or more controllers (not illustrated),which are capable of receiving signals from and activating one or moreof the pumps 46, 78, 113 and one or more of the valves 42, 52, 54,62-70, 72, 74, 76, 80, 106, 107, 116, 130, and receiving input from airsensors 124, 126, and conductivity detector 110, conductivity cell 111,temperature detector 112, and conductivity sensor 134. For example, insome implementations, a Microchip PIC18F6410 (manufactured by MicrochipTechnology, Inc. (Chandler, Ariz.)) is used for the controller.

During treatment, liquid, typically purified water, is delivered fromthe hydrochamber 24 to the bag 82. The water mixes with the sodiumbicarbonate powder in the bag 82 to produce the sodium bicarbonatesolution used as the dialysate. While the sodium bicarbonate solution isdescribed as being used as the dialysate in this system, it should beunderstood that one or more additional additives can also be added tothe sodium bicarbonate solution to form the dialysate. The dialysate isdelivered to the dialyzer 11 via the balancing chambers 26, 28, whichensure that the volume of dialysate delivered to the dialyzer 11 isapproximately equal to the volume of spent dialysate exiting thedialyzer 11. The dialysate passes through the dialyzer 11 along with apatient's blood to filter the blood and remove toxins from the blood.The spent dialysate containing the removed toxins is then sent to thedrain 34 via the balancing chambers 26, 28.

FIG. 4 illustrates an example conductivity level of the sodiumbicarbonate solution during operation of the machine. The conductivitylevel of the solution when the layer of solution 95 is maintained at athickness of 0.5 inch to 1.5 inch above the sodium bicarbonate powderlayer 93 in the bag 82 is shown by solid line 410 in FIG. 4, while thedashed line 408 shows the conductivity level of solution that typicallyresults in systems that allow thicker layers of solution to accumulateover the sodium bicarbonate powder layer.

Still referring to FIG. 4, at the beginning portion 402 of theoperation, the bag 82 is being filled with purified water to produce thedialysate. During this beginning portion 402, the conductivity of thebicarbonate solution rises, for example, from 0 mS/cm to about 60 mS/cm.The beginning portion 402 lasts, for example, about three to tenminutes, depending on the flow rate of the purified water into the bag82. During the beginning portion 402, the bag continues to fill and theoperation of the valve 54 is not affected by the operation of thebicarbonate pump 113. As the bag 82 fills, the pressure within the bagalso increases. The liquid typically continues to be introduced into thebag 82 until the pressure within the bag 82 reaches a predeterminedlevel (e.g., 90 mmHg).

During the middle portion 404 of the operation of the machine, thedialysate is passed through the dialyzer 11 along with blood of thepatient to perform the dialysis treatment. The conductivity of thebicarbonate solution remains at a relatively high and steady level(e.g., around 60 mS/cm) during this middle portion 404. The relativelyhigh and steady level lasts for the majority of the operation of themachine. During the middle portion 404, the volume of liquid added tothe bag is approximately equal to the volume of liquid pumped by thebicarbonate pump 113, as discussed below.

As the solid bicarbonate is depleted, the solution becomes more dilutedtowards the end portion 406 of the operation. Accordingly, theconductivity of the solution decreases, for example, to 0 mS/cm, as thesolution increases in ratio of liquid to bicarbonate. During the endportion 406, the volume of liquid added to the bag is approximatelyequal to the volume of liquid pumped by the bicarbonate pump 113. Thepressure sensor 117 may be used to monitor the pressure in the bag andensure that the pressure in the bag does not drop below 20 mmHg. Asevident from comparing the trajectory of the dashed line 408, whichrepresents the conductivity of bicarbonate solution over time using aconventional system that does not maintain a 0.5 inch to 1.5 inch layerof liquid above the sodium bicarbonate, to the trajectory of the solidline 410, which represents the conductivity of bicarbonate solution overtime while maintaining a 0.5 inch to 1.5 inch layer of liquid above thesodium bicarbonate, the concentration of the sodium bicarbonate solutioncan be increased (comparatively) during the end portion 406 of theoperation of the machine by providing continued agitation of the sodiumbicarbonate solution in the bag, which results from the thinner layer ofsolution over the sodium bicarbonate powder.conductivityconductivityconductivityconductivityThe increasedconductivityconductivityconductivity is the result of increased levelsof sodium bicarbonate in the solution. Increasing the levels of sodiumbicarbonate in the solution can increase the useful life of the solidbicarbonate.

Referring again to FIG. 2, as discussed above, the bicarbonate pump 113pumps sodium bicarbonate solution from the bag 82 and air separationchamber 102 into the mainline segment 20 c. The bicarbonate pump 113measures the volume of sodium bicarbonate solution pumped into themainline segment 23. The bicarbonate pump 113 reports the volume ofsodium bicarbonate solution to a controller (not shown).

Periodically, for example, once every two strokes of the balancingchambers 26, 28, the controller determines how long to open the valve 54in order to replenish the volume of liquid into the bag. The controllermay determine a period of time to open the valve 54 based on thereported volume of bicarbonate solution pumped from the bag 82 and theknown characteristics of the valve 54. For example, if opening the valvemay allow the passage of 1 ml of liquid through the valve per second andthe bicarbonate pump 113 reports that a volume of 3 ml has been pumpedfrom the bag 82, then the controller determines to open the valve 54 for3 seconds.

The amount of time that the value is opened is proportional to theamount of liquid to be added to the bag 82. For example, the amount ofliquid passing through a specific type of valve in a given period oftime can be determined using a look-up table of the type shown below. Ofcourse, it should be understood that different valves may have differentperformance characteristics.

Time (ms) Volume (ml) 50 1.86 40 1.52 30 1.18 20 0.84 10 0.3

The controller opens the valve 54 to allow liquid into the bag 82 forthe determined time. As a result the controller maintains the layer ofliquid over the layer of dry form sodium bicarbonate to the appropriatedepth as described above.

During the operation of the dialysis machine, as the bag 82 empties, thepressure detected by the pressure sensor 117 decreases. For example, thepressure may decrease from 90 mmg to 60-70 mmg. Generally the pressurewill not be permitted to drop below 20 mmg as this indicates that thelevel of liquid in the bag 82 has dropped below an acceptable level.

If the level of the liquid in the bag 82 becomes too low, severalconsecutive air vents can occur in the air separation chamber 102. Inresponse to the repeated air vents, the controller may open the valve 54to allow liquid to enter the bag 82 independent of the bicarbonate pump113.

FIG. 5 is a flow chart illustrating a method of increasing thedissolution of sodium bicarbonate into the solution in the bag 82.Referring to FIG. 5, the controller performs an initial fill of the bag82. The initial fill of the bag includes opening the valve 54 to allowliquid to enter the bag. As the liquid saturates the sodium bicarbonate,the pressure in the bag, as measured by the pressure sensor 117increases. The fill process ends when the requisite pressure of 90 mmgis obtained.

The controller waits for two cycles of the balance chamber (504). Duringthis period, signals are received from the bicarbonate pump 113indicating the volume of bicarbonate solution that has been pumped fromthe bag 82.

The controller sums the volume of bicarbonate solution pumped from thebag (506) during each pulse, as reported by the bicarbonate pump 113.

The controller determines an amount of time to open the value (508). Theduration is determined in order to add the same volume of liquid to thebag 82 as was removed from the bag 82. The controller compares thevolume of solution pumped to the characteristics of the valve 54 todetermine the amount of time to keep the valve 54 open.

The controller opens the valve 54 for the determined amount of time(510). While the valve 54 is open, liquid flows through the subsystemline 56 and into the bag 82.

While the controller is controlling the flow of liquid into the bag 82,the controller is monitoring the pressure sensor 117 and the airseparation chamber 102. If the pressure measured by the pressure sensor117 drops to 20 mmg, the controller opens the valve 54 to allow moreliquid to enter the bag. If the controller detects several consecutiveventings of the air separation chamber, the controller opens the valve54 to add additional liquid to the bag 82.

While the layer of liquid 95 in the bag 82 has been described as beingmaintained by adding liquid to the bag based on the volume of liquidpumped from the bag, the layer of liquid 95 may alternatively bemaintained using other techniques. In certain implementations, the layerof liquid 95 is maintained at a desired depth of thickness (e.g., 0.5inch to 1.5 inch) by comparing a measure of the pressure in the bag 82,as measured by the pressure sensor 117, to an expected pressure thatchanges based on the operation of the dialysis machine. For example,after the beginning portion 402 of the operation the expected pressurewill gradually decrease as the bag 82 empties during the middle portion404 and end portion 406 of the operation. The controller may determine aperiod of time to open the valve 54 based on the difference between themeasured pressure and the expected pressure.

The layer of liquid 95 may alternatively be maintained by adding liquidto the bag based on a comparison of the weight in the bag 82, asdetermined by a scale or other weight sensor (not shown), to an expectedweight that changes based on the operation of the dialysis machine. Forexample, after the beginning portion 402 of the operation the expectedweight will gradually decrease as the bag 82 empties during the middleportion 404 and end portion 406 of the operation. The controller maydetermine a period of time to open the valve 54 based on the differencebetween the measured weight and the expected weight.

As another example, the layer of liquid 95 may be maintained by anoptical sensor (not shown) that determines the depth of the layer ofliquid 95 relative to the layer of sodium bicarbonate 93. The controllermay add liquid to the bag 82 by opening the valve 54 until the opticalsensor determines that the depth of the layer of liquid 95 is within anacceptable range (for example, 0.5 to 1.5 inch deep).

In other implementations, the layer of liquid 95 in the bag 82 ismaintained by comparing a number of balance chamber cycles during theoperation of the dialysis machine to a table.

While the liquid referenced in this disclosure as being introduced tothe bag 82 to form the bicarbonate solution or dialysate will typicallybe purified water, it is intended that the terms “liquid” and “liquids”will encompass other appropriate liquids for the purposes of thedisclosed method and arrangement.

As used in this disclosure, the term “air separation chamber” is used tosignify a structure that allows the separation of gases from a solution,and permits the separate removal of each through respective outlets.Further, as used in this disclosure, the term “gas” or “gases” is notlimited to air, but may include other gases, such as carbon dioxide,etc.

While the valve 42 illustrated in FIG. 2 has been described as beingused to control flow to the mainline segment 20 a, the pressureregulator 40 may alternately or additionally control the pressure of thefluid (and thus the flow of the fluid) as it passes through the sectionof the mainline segment 20 a.

While the bag 82 has been described as a flexible bag, any otherappropriate structure may alternatively be used. For example, a rigidcontainer, a semiflexible container, or a flexible container can beused.

While the bag 82 has been described as containing powdered sodiumbicarbonate concentrate to form sodium bicarbonate solution, any ofvarious other solid concentrates (e.g., powdered concentrates) canalternatively be used to form different types of solutions. In someimplementations, for example, other types of salts can be provided inthe bag. Examples of other types of solid concentrates that can be usedinclude sodium actetate concentrate.

While the venting structure 43 is described to be included in the thirdchamber 24 c of the hydrochamber 24, other venting structures can beincluded in other chambers.

While only one controller is described, multiple controllers mayalternatively be used.

Implementations of the subject matter and the operations described inthis specification can be implemented in digital electronic circuitry,or in computer software, firmware, or hardware, including the structuresdisclosed in this specification and their structural equivalents, or incombinations of one or more of them. Implementations of the subjectmatter described in this specification can be implemented as one or morecomputer programs, i.e., one or more modules of computer programinstructions, encoded on computer storage medium for execution by, or tocontrol the operation of, data processing apparatus. Alternatively or inaddition, the program instructions can be encoded on an artificiallygenerated propagated signal, for example, a machine-generatedelectrical, optical, or electromagnetic signal, that is generated toencode information for transmission to suitable receiver apparatus forexecution by a data processing apparatus. A computer storage medium canbe, or be included in, a computer-readable storage device, acomputer-readable storage substrate, a random or serial access memoryarray or device, or a combination of one or more of them. Moreover,while a computer storage medium is not a propagated signal, a computerstorage medium can be a source or destination of computer programinstructions encoded in an artificially generated propagated signal. Thecomputer storage medium can also be, or be included in, one or moreseparate physical components or media (for example, multiple CDs, disks,or other storage devices).

The operations described in this specification can be implemented asoperations performed by a data processing apparatus on data stored onone or more computer-readable storage devices or received from othersources.

The term “data processing apparatus” encompasses all kinds of apparatus,devices, and machines for processing data, including by way of example aprogrammable processor, a computer, a system on a chip, or multipleones, or combinations, of the foregoing The apparatus can includespecial purpose logic circuitry, for example, an FPGA (fieldprogrammable gate array) or an ASIC (application specific integratedcircuit). The apparatus can also include, in addition to hardware, codethat creates an execution environment for the computer program inquestion, for example, code that constitutes processor firmware, aprotocol stack, a database management system, an operating system, across-platform runtime environment, a virtual machine, or a combinationof one or more of them. The apparatus and execution environment canrealize various different computing model infrastructures, such as webservices, distributed computing and grid computing infrastructures.

A computer program (also known as a program, software, softwareapplication, script, or code) can be written in any form of programminglanguage, including compiled or interpreted languages, declarative orprocedural languages, and it can be deployed in any form, including as astandalone program or as a module, component, subroutine, object, orother unit suitable for use in a computing environment. A computerprogram may, but need not, correspond to a file in a file system. Aprogram can be stored in a portion of a file that holds other programsor data (for example, one or more scripts stored in a markup languagedocument), in a single file dedicated to the program in question, or inmultiple coordinated files (for example, files that store one or moremodules, sub programs, or portions of code). A computer program can bedeployed to be executed on one computer or on multiple computers thatare located at one site or distributed across multiple sites andinterconnected by a communication network.

The processes and logic flows described in this specification can beperformed by one or more programmable processors executing one or morecomputer programs to perform actions by operating on input data andgenerating output. The processes and logic flows can also be performedby, and apparatus can also be implemented as, special purpose logiccircuitry, for example, an FPGA (field programmable gate array) or anASIC (application specific integrated circuit).

Processors suitable for the execution of a computer program include, byway of example, both general and special purpose microprocessors, andany one or more processors of any kind of digital computer. Generally, aprocessor will receive instructions and data from a read only memory ora random access memory or both. The essential elements of a computer area processor for performing actions in accordance with instructions andone or more memory devices for storing instructions and data. Generally,a computer will also include, or be operatively coupled to receive datafrom or transfer data to, or both, one or more mass storage devices forstoring data, for example, magnetic, magneto optical disks, or opticaldisks. However, a computer need not have such devices. Moreover, acomputer can be embedded in another device, for example, a mobiletelephone, a personal digital assistant (PDA), a mobile audio or videoplayer, a game console, a Global Positioning System (GPS) receiver, or aportable storage device (for example, a universal serial bus (USB) flashdrive), to name just a few. Devices suitable for storing computerprogram instructions and data include all forms of nonvolatile memory,media and memory devices, including by way of example semiconductormemory devices, for example, EPROM, EEPROM, and flash memory devices;magnetic disks, for example, internal hard disks or removable disks;magneto optical disks; and CD ROM and DVD-ROM disks. The processor andthe memory can be supplemented by, or incorporated in, special purposelogic circuitry.

To provide for interaction with a user, implementations of the subjectmatter described in this specification can be implemented on a displaydevice (e.g., the display device of the dialysis machine 12), forexample, a CRT (cathode ray tube) or LCD (liquid crystal display)monitor, for displaying information to the user and a keyboard or keypadand/or a pointing device, for example, a mouse or a trackball, by whichthe user can provide input to the computer. Other kinds of devices canbe used to provide for interaction with a user as well; for example,feedback provided to the user can be any form of sensory feedback, forexample, visual feedback, auditory feedback, or tactile feedback; andinput from the user can be received in any form, including acoustic,speech, or tactile input.

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anydisclosures or of what may be claimed, but rather as descriptions offeatures specific to particular implementations of particulardisclosures. Certain features that are described in this specificationin the context of separate implementations can also be implemented incombination in a single implementation. Conversely, various featuresthat are described in the context of a single implementation can also beimplemented in multiple implementations separately or in any suitablesubcombination. Moreover, although features may be described above asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

What is claimed is:
 1. A dialysis system comprising: a containercontaining a dissolvable solid concentrate; an input line connected tothe container and to a valve that controls the flow of liquid into thecontainer; an output line connected to the container and to a pump; anda data processing apparatus connected to the valve and configured for:introducing liquid into the container through the line in a manner sothat a layer of solution above the solid concentrate is maintained at adepth that allows the liquid introduced into the container to agitatethe solution adjacent to the solid concentrate to cause mixing of thesolid concentrate with the solution.
 2. The system of claim 1, whereinthe solid concentrate is a salt.
 3. The system of claim 2, wherein thesalt is sodium bicarbonate.
 4. The system of claim 1, wherein the dataprocessing apparatus is further configured for: obtaining a measurementof a volume of solution pumped from the container by the pump during afirst period of time; and determining a second period of time based onthe measurement; wherein introducing the liquid comprises opening thevalve for the second period of time.
 5. The system of claim 4, whereinthe first period of time is based on a number of cycles of a balancechamber.
 6. The system of claim 4, further comprising a dialyzerconnected to the output line.
 7. The system of claim 1, wherein thedepth of the layer of solution is 0.5 to 1.5 inch.
 8. The system ofclaim 1, wherein the data processing apparatus is further configuredfor: obtaining a measurement of pressure within the container; comparingthe measurement to an expected pressure; and determining a period oftime based on the comparison; wherein introducing the liquid comprisesopening a valve that controls the flow of the liquid into the containerfor the period of time.
 9. The system of claim 1, wherein the dataprocessing apparatus is further configured for: obtaining a measurementof the weight of the container; comparing the measurement to an expectedweight; and determining a period of time based on the comparison;wherein introducing the liquid comprises opening a valve that controlsthe flow of the liquid into the container for the period of time.